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DiaMedica gets phase I/II clinical trial regulatory approval for DM-199

Published: 20:59 08 Apr 2013 BST

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DiaMedica (CVE:DMA), a  clinical stage Canadian biopharmaceutical company focused on novel therapies to treat diabetes, obtained regulatory approval to start an anticipated 76 subject phase one and two clinical trial for its lead compound, DM-199. 

The clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of DM-199 in 36 healthy volunteers and in 40 Type 2 diabetes patients, the Winnipeg, Manitoba-based company said in a statement on Monday.

Data from this trial, to be conducted in the Netherlands, will also support future DM-199 clinical trial regulatory filings for Type 1 and Type 2 diabetes and in other potential indications, the company said.

"We have high hopes for this drug in improving the lives of diabetes patients," the company said, citing CEO Rick Pauls. 

The Phase one stage is a randomized, controlled trial to evaluate the safety, tolerability and pharmacokinetics of DM-199 in healthy volunteers. In the phase two stage, Type 2 diabetes patients will initially be assessed for acute safety and efficacy in single ascending dose study via a meal tolerance test.

A follow on 28-day dosing double-blinded placebo-controlled study will be done to assess the efficacy and safety of longer term DM-199 use. 

Efficacy endpoints will include measuring HbA1c, post-meal blood glucose, average blood glucose and glucose regulatory peptides levels over the 28-day study period.

DM-199 is a recombinant human protein that represents a new approach to treating Type 1 and Type 2 diabetes.

Shares of DiaMedica gained 1.2 percent to 88 cents at market close in Toronto on Monday, giving the company a market value of $44.5 million. It earlier touched as high as 90 cents. The stock has surrendered 27 percent so far this year.

 

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